OncoMatch/Clinical Trials/NCT05659628
CD19 CAR-T Expressing IL-7 and CCL19 Combined With Anti-PD1 in RR-DLBCL
Is NCT05659628 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies CD19-7×19 CAR-T combined with Tislelizumab for diffuse large b-cell lymphoma.
Treatment: CD19-7×19 CAR-T combined with Tislelizumab — The goal of this clinical trial is to test CD19-7×19 CAR-T cells combined with Tislelizumab in refractory and relapsed diffuse large B lymphoma. The main question\[s\] it aims to answer are: question 1：What is the safety of CD19-7×19 CAR-T cells combined with Tislelizumab in the treatment of relapsed or refractory diffuse large B-cell lymphoma. question 2：What is the efficacy of CD19-7×19 CAR-T cells combined with Tislelizumab in the treatment of relapsed or refractory diffuse large B-cell lymphoma. Participants will be asked to receive clinical evaluation before CAR-T, including physical examination, blood routine test, biochemical test, imaging test, etc.Peripheral blood lymphocytes will be collected for preparation of CAR-T cells after enrollment. Pretreatment chemotherapy with fludarabine and cyclophosphamide will be used before CAR-T infusion. On the 31st day after CAR-T infusion, Tislelizumab 200mg was given once every 21 days for 6 cycles. Participants will be required to report concomitant medication and adverse events, and their disease was evaluated throughout the study.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Diffuse Large B-Cell Lymphoma
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CD19 positive
Performance status
ECOG 0–3(Limited self-care)
Demographics
Prior therapy
Must have received: CD20 monoclonal antibody (rituximab)
Previous treatment for patients with diffuse large B cell lymphoma must include rituximab (CD20 monoclonal antibody)
Must have received: anthracycline
Previous treatment for patients with diffuse large B cell lymphoma must include...anthracyclines
Cannot have received: CAR-T cell therapy
Exception: within 3 months before this CAR-T treatment
Any target CAR-T treatment was performed within 3 months before this CAR-T treatment
Cannot have received: PD-1 monoclonal antibody
Previously used any commercially available PD-1 monoclonal antibody
Cannot have received: autologous hematopoietic stem cell transplant
Exception: within 6 weeks
Autologous hematopoietic stem cell transplantation was performed within 6 weeks
Cannot have received: cytotoxic chemotherapy
Exception: within 2 weeks before cell collection
Cytotoxic drugs, glucocorticoids and other targeted drugs were received within 2 weeks before cell collection
Cannot have received: glucocorticoid
Exception: within 2 weeks before cell collection
Cytotoxic drugs, glucocorticoids and other targeted drugs were received within 2 weeks before cell collection
Cannot have received: targeted therapy
Exception: within 2 weeks before cell collection
Cytotoxic drugs, glucocorticoids and other targeted drugs were received within 2 weeks before cell collection
Lab requirements
Blood counts
Absolute value of peripheral blood neutrophils ≥ 1000/μl. Platelets ≥ 45000/μl
Kidney function
creatinine < 1.5mg/dL
Liver function
ALT/AST < 2.5x ULN; Total bilirubin < 1.5mg/dL
Cardiac function
Cardiac ejection fraction (EF) ≥ 50%
creatinine < 1.5mg/dL; ALT/AST Less than 2.5 times of normal upper limit; Total bilirubin < 1.5mg/dL; Cardiac ejection fraction (EF) ≥ 50%; Absolute value of peripheral blood neutrophils ≥ 1000/μl. Platelets ≥ 45000/μl
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT05659628 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior CAR-T cell therapy, PD-1 monoclonal antibody, autologous hematopoietic stem cell transplant disqualifies patients from enrollment.
Does this trial require CD19?
Yes, CD19 positive is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify